Diagnostic approach using ERCP-guided transpapillary forceps biopsy or EUS-guided fine-needle aspiration biopsy according to the nature of suspected malignant biliary stricture

Diagnostic approach using ERCP-guided transpapillary forceps biopsy or EUS-guided fine-needle aspiration biopsy according to the nature of suspected malignant biliary stricture - Diagnostic approach using ERCP-guided transpapillary forceps biopsy or EUS-guided fine-needle aspiration biopsy according to the nature of suspected malignant biliary stricture

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016886

Enrollment

174

Registered

2015-03-23

Start date

2012-01-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant bile duct stricture

Interventions

EUS-guided fine-needle aspiration biopsy Transpapillary forceps biopsy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) the presence of biliary stricture due to a thickened bile duct wall or pancreatobiliary mass revealed by cross-sectional radiologic images, computed tomography (CT), and/or magnetic resonance imaging (MRI), (2) clinical findings of obstructive jaundice and/or cholangitis, (3) age >18 years, and (4) ability to provide informed consent.

Exclusion criteria

Exclusion criteria: (1) underlying pancreatobiliary disease without clinical findings suggestive of malignancy (e.g., primary biliary cirrhosis or postoperative biliary stricture), (2) the presence of any contraindication for ERCP, (3) coagulopathy (international normalized ratio >1.5 or platelet count <80,000/mm3 (4) difficulty to perform ERCP due to altered gastrointestinal anatomy or a significant duodenal obstruction.

Design outcomes

Primary

Measure	Time frame
the accuracy of the diagnostic approach using ERCP-guided TPB and EUS-FNAB according to the type of biliary stricture in patients with suspected MBS	—

Secondary

Measure	Time frame
the accuracy of initial TPB, technical failure and adverse event rates of ERCP-guided TPB and EUS-FNAB	—

Countries

Asia(except Japan)

Contacts

Public ContactHyun Jong Choi

Department of Internal Medicine, Soon Chun Hyang University School of Medicine Gastroenterology

joseph@schmc.ac.kr+82-32-621-5094

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026